Methods and devices for treating severe peripheral bacterial infections

Abstract

The present invention relates to novel methods and devices for treating severe bacterial infections, such as septicemia, using an extracorporeal adsorption container. The device has a solid support disposed and confined within the container and a binding means associated with the solid support that is specific for affixing an infecting bacterium that is causing the severe peripheral bacterial infection and/or bacterial toxins from the bacterium. By passing the infected blood through the container. at least a portion of the infecting bacterium and/or bacterial toxins are removed. The treated blood is returned to the patient.

1. A device for treating a patient having a peripheral bacterial infection, wherein the device comprises:
 at least one adsorption container having an inlet means and an outlet means, where the inlet means and outlet means allow the patient's blood, in a whole or separated form, to be circulated through the adsorption container; 
 a first binding means associated with a solid support, wherein the first binding means is specific for affixing an infecting bacterium that is causing the severe peripheral bacterial infection, and the solid support is disposed and confined within the adsorption container; 
 thereby allowing for the removal of at least a portion of the infecting bacterium when the patient's blood is circulated through the adsorption container. 
 
     
     
       2. The device of  claim 1  wherein the solid support has a surface area to volume ratio of at least about 4 to 1. 
     
     
       3. The device of  claim 1  wherein the solid support is selected from the group consisting of coated beads, hollow fibers, and membranes. 
     
     
       4. The device of  claim 1  wherein the first binding means is present in an amount sufficient to remove at least 1 mg of infecting bacteria. 
     
     
       5. The device of  claim 1  wherein the first binding means is adsorbed or bonded to the solid support. 
     
     
       6. The device of  claim 1  wherein the infecting bacterium is a  bacillus, meningococcus, streptococcus, staphylococcus , or  paratuberculosis  species. 
     
     
       7. The device of  claim 6 , wherein the infecting bacterium is an antibiotic resistant bacterium. 
     
     
       8. The device of  claim 7 , wherein the antibiotic resistant bacterium is a  staphylococcus  species. 
     
     
       9. The device of  claim 1  further comprising a second binding means,
 wherein the second binding means is associated with a solid support that is disposed and confined within an adsorption container, which may be the same adsorption container in which the first binding means is confined or it may be a separate adsorption container, 
 and wherein the second binding means is specific for affixing at least one toxin produced by an infecting bacterium that is causing the severe peripheral bacterial infection, 
 thereby allowing for the removal of at least a portion of the toxin and a portion of the infecting bacterium when the patient's blood is circulated through the adsorption container or adsorption containers. 
 
     
     
       10. The device of  claim 9  wherein the first binding means and the second binding means are associated with the same solid support. 
     
     
       11. The device of  claim 9  wherein the first binding means and the second binding means are both confined in a single adsorption container. 
     
     
       12. The device of  claim 9  wherein the first and second binding means are confined in separate adsorption containers. 
     
     
       13. The device of  claim 9  wherein the second binding means is present in an amount sufficient to remove at least 1 μg of toxin and the first binding means is present in an amount sufficient to remove at least 1 mg of infecting bacterium. 
     
     
       14. The device of  claim 9 , wherein the infecting bacterium is an antibiotic resistant bacterium. 
     
     
       15. The device of  claim 9 , wherein the antibiotic resistant bacterium is a  staphylococcus  species. 
     
     
       16. A method for treating a patient having a severe peripheral bacterial infection, the method comprising circulating the patient's blood, in whole or separated form, through an adsorption container and returning the treated blood to the patient,
 wherein the adsorption container comprises an inlet means and an outlet means to allow blood to circulate through the adsorption container; 
 a solid support is disposed and confined within the adsorption container; 
 and a first binding means that is specific for affixing an infecting bacterium that is causing the severe peripheral bacterial infection is associated with the solid support; 
 thereby removing at least a portion of the infecting bacterium from the patient's blood when the blood is circulated through the adsorption container; 
 wherein an antibiotic treatment of the patient is curtailed until the infecting bacterial load has been lowered to an acceptable risk level. 
 
     
     
       17. The method of  claim 16  wherein the blood is circulated through the adsorption container until the bacterial load has been reduced to a level such that the use of an antibiotic does not put the patient at a significant risk of induced bacteremia or septicemia. 
     
     
       18. The method of  claim 16  also comprising using a pump means to circulate the blood through the adsorption container. 
     
     
       19. The method of  claim 16  in which the blood is monitored for the reduction in the level of bacteria. 
     
     
       20. The method of  claim 16  wherein the infecting bacterium is a  bacillus, meningococcus, streptococcus, staphylococcus , or  paratuberculosis  species. 
     
     
       21. The method of  claim 20 , wherein the infecting bacterium is an antibiotic resistant bacterium. 
     
     
       22. The method of  claim 21 , wherein the antibiotic resistant bacterium is a  staphylococcus  species. 
     
     
       23. The method of  claim 16 , wherein the adsorption container further comprises a second binding means,
 wherein the second binding means is associated with a solid support that is disposed and confined within an adsorption container, which may be the same adsorption container in which the first binding means is confined or it may be a separate adsorption container, 
 and wherein the second binding means is specific for affixing at least one toxin produced by an infecting bacterium that is causing the severe peripheral bacterial infection, 
 thereby allowing for the removal of at least a portion of the toxin and a portion of the infecting bacterium when the patient's blood is circulated through the adsorption container or adsorption containers. 
 
     
     
       24. The method of  claim 23  wherein the infecting bacterium is a  bacillus, meningococcus, streptococcus, staphylococcus , or  paratuberculosis  species. 
     
     
       25. The method of  claim 24 , wherein the infecting bacterium is an antibiotic resistant bacterium. 
     
     
       26. The method of  claim 25 , wherein the antibiotic resistant bacterium is a  staphylococcus  species.